BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PSG 5.5mm Cannulated Pedicle Screw System

    Reg #: 3010197239 · FEI: 3010197239 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    CAMBER SPINE TECHNOLOGIES
    Registration Number
    3010197239
    FEI Number
    3010197239
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    501 Allendale Rd
    City
    King of Prussia
    State
    PA
    ZIP
    19406
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141282

    Owner / Operator

    Firm Name
    Camber Spine/Medical Technologies
    Operator Number
    10043961
    Address
    501 Allendale Rd.
    City
    King of Prussia
    State
    PA
    Postal Code
    19406
    Country
    US

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI

    Proprietary Names

    PSG 5.5mm Cannulated Pedicle Screw System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility